FDA approves ingestible sensor for medication adherence monitoring
REDWOOD CITY, Calif. — Big Doctor is watching you — to make sure you’re taking your drugs as prescribed, that is.
It’s not dystopian, but it sure sounds like the stuff of science fiction: The Food and Drug Administration approved Monday a tiny, ingestible sensor that can be integrated into drugs to monitor patients’ prescription drug adherence.
The sensor, made by Proteus Digital Health, is powered by contact with stomach fluid and works by transmitting a signal that determines the identity and timing of a drug’s ingestion to a patch worn on the skin. The patch then transmits the information to a mobile app, which can be accessed by clinicians and caregivers. The patch also collects such data as heart rate, body position and activity.
"The FDA validation represents a major milestone in digital medicine," Scripps Research Institute genomics professor Eric Topol said. "Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management."
Mass. lawmakers pass healthcare bill that expands use of limited-service clinics
BOSTON — Massachusetts lawmakers passed a massive healthcare bill that seeks to control healthcare costs and expands the services of limited-service clinics to allow for anything within the scope of practice for a nurse practitioner.
The legislation, which Gov. Deval Patrick said he would sign into law, includes an array of other cost-curbing provisions and is estimated to save as much as $200 billion in healthcare spending over the next 15 years.
“I congratulate the legislature for approving legislation to contain healthcare costs. With over 98% of our residents insured today, we’ve shown the nation how to extend coverage to everyone. Now we are poised to do the same on controlling costs. I look forward to signing this bill, and standing alongside the legislators and many stakeholders who came together once again for the good of the working families and business owners of the Commonwealth,” Patrick said in a prepared statement.
The 350-page plan not only calls for the monitoring of growth in health spending and the enforcement of spending targets to contain healthcare costs in the state, but also promotes the availability of limited-service clinics as a point of access for healthcare services within the full scope of practice of a nurse practitioner.
The new definition of limited services includes diagnosis treatment, management and monitoring of acute and chronic disease, and wellness and preventative services, all within the scope and practice of nurse practitioners. The Department of Public Health will be required to promulgate regulations pursuant to this.
“We authorized the establishment of limited-service clinics back in 2008 in healthcare legislation that we passed and we left to the Department of Public Health the responsibility of coming up with regulations governing them. I think some aspects of the medical society certainly weighed in heavily on the development of those regulations because the type of things that the limited-service clinics could do was seriously restricted, particularly prevention and wellness activities, which nurse practitioners are very good at and they are certainly skilled in providing and they couldn’t do a lot of them,” Sen. Richard Moore and an author of the bill told Drug Store News. “In order to expand the use of the limited-service clinics and make them more available, the bill that we just passed and that the governor will sign next week, will allow the limited-service clinic to do whatever is within the scope of practice of the nurse practitioner in the state.”
The cost containment bill also encourages limited-service clinics to work with healthcare systems to ensure that patients are aligned with a primary care practitioner, if they don’t already have one.
The bill becomes effective in 90 days and the Department of Public Health will be required to promulgate regulations. Moore said he estimates that within six months the expansion of services of a limited-service clinic will be fully operational.
“Most people have a primary care doctor that they deal with and yet when something happens … that’s not a true emergency and they call the doctor for an appointment it is a couple of weeks before they can get an appointment. … We would rather have them, if it is not a major issue, go to a clinic or a health center, rather than to the emergency department, where it is very expensive care and it also clogs up the emergency department from other true emergencies that are there. So, it is really the need to expand urgent care opportunities,” Moore said.
In January 2008, Massachusetts health officials approved regulations allowing for limited-service medical clinics, marking the end of a long review process. Sparking the move to create specialized regulations: CVS’ application to open a MinuteClinic in one of its stores in Weymouth. Today, MinuteClinic operates 31 clinics within the state.
According to the state Public Health Council, early in the application review process it became clear that Department of Public Health regulations governing medical clinics did not address the operation of medical clinics with limited scope of services. Rather than consider applications requiring numerous waivers from full-service clinic regulations, the department decided to create a specialized set of rules.
In response to the legislation, Andrew Sussman, president of MinuteClinic and SVP/associate chief medical officer of CVS Caremark, said in a statement sent to Drug Store News, "We’re very pleased to be able to bring an expanded scope of services to MinuteClinic patients in Massachusetts in areas such as monitoring of chronic diseases and prevention and wellness offerings. These services are well within the scope of practice of our nurse practitioners and have been welcomed by our patients in the additional 24 states where we have MinuteClinic operations."
Plackers introduces floss for tight teeth, sensitive gums
GRAND RAPIDS, Mich. — Disposable dental flosser maker Plackers has expanded its porfolio with the launch of its new GentleSlide flossers.
Featuring a shred-resistant polytetrafluoroethylene floss technology, GentleSlide is designed to make flossing between tight teeth easy and comfortable, and is gentle on sensitive gums. People with tight teeth and sensitive gums often forgo flossing altogether because of the discomfort. The floss has a cool mint flavoring.
The suggested retail price for a 90-count package of GentleSlide flossers is $2.99.